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| Name | Class |
|---|---|
| Sponsor GmbH | OTHER |
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This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK),Pharmacodynamic characteristics, immunogenicity and antitumor activity of JS207 in patients with advanced malignant tumor. The Recommended dose for phase II trial (RP2D) will be determined based on the safety, tolerability, pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS207 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS207 | Drug | Patients will receive specific dose of JS207 via intravenous infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT)、adverse event(AE) | Incidence and severity of DLT, adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance | 2 Years |
| Maximum tolerated dose (MTD),RP2D | Maximum tolerated dose (MTD), Recommended dose for phase II trial | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration(Cmax) | The highest plasma drug concentration that can be achieved after medication | 2 years |
| Time to peak(Tmax) | After a single dose, the time of peak blood concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Shandong First Medical University | Jinan | Shandong | 250117 | China |
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| 2 years |
| Elimination half life(t1/2) | The time it takes the blood to reduce the concentration of the drug to half | 2 years |
| Progression free survival(PFS) | The time from first dose to Disease progression or death | 2 years |
| Overall survival (OS) | The time from first dose to death from any cause | 2 years |
| Immunogenicity | Incidence of Anti-Drug Antibody (ADA) | 2 years |
| Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1) | Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR) | 2 years |